Component, Cast
FDA product code LGF · Class I (low risk) · 21 CFR 888.5940 · Orthopedic
31510(k) clearances
0PMA approvals
0recalls
GMP exemptexempt from GMP rules
Manufacturers
- Martin Medical 6
- Johnson & Johnson Professionals, Inc. 2
- Clinitex Medical Corp. 2
- Carapace, Inc. 2
- Buckman Co., Inc. 2
- Orthopedic Systems, Inc. 1
- Danek Medical, Inc. 1
- Mark One Healthcare Products 1
- Seton Products, Inc. 1
- Orthopedic Technology, Inc. 1
- Depuy, Inc. 1
- The Healthcare Group Laboratories, Inc. 1
- Military Engineering, Inc. 1
- Alba Health Care 1
- Synthetic Mfg., Inc. 1
- Secol Co. 1
- Hawthorne Products, Inc. 1
- Beiersdorf, Inc. 1
- Landec Corp. 1
- Noble Fiber Technologies, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043526 | Silverseal Tubular Wound Dressing with X-StaticLGF · Traditional | Noble Fiber Technologies, Inc. | 03/10/2005SE |
| K973420 | Clinitex Cast PaddingLGF · Traditional | Clinitex Medical Corp. | 12/09/1997SE |
| K973417 | Clinitex StockinetteLGF · Traditional | Clinitex Medical Corp. | 12/09/1997SE |
| K955320 | Protec Cotton Padding BandageLGF · Traditional | Derivadas Degasa S.A. DE C.V. | 01/26/1996SE |
| K932507 | Quick-Cast ImmobilizerLGF · Traditional | Landec Corp. | 02/23/1994SE |
| K931672 | Carapace Sterile Cast PaddingLGF · Traditional | Carapace, Inc. | 12/15/1993SE |
| K910274 | Artiflex(Tm)LGF · Traditional | Beiersdorf, Inc. | 03/05/1991SE |
| K903946 | Cool Cast(R)LGF · Traditional | Hawthorne Products, Inc. | 12/31/1990SE |
| K896634 | Caraglas Xtra Synthetic Casting TapeLGF · Traditional | Buckman Co., Inc. | 06/14/1990SE |
| K883294 | Synthetic Cast TapeLGF · Traditional | Carapace, Inc. | 08/30/1988SE |
| K874880 | Colored Casting Tape Caraglas(Tm GreenLGF · Traditional | Synthetic Mfg., Inc. | 12/30/1987SE |
| K873722 | Pedestal Walking Heel Product No. 4183-133LGF · Traditional | Martin Medical | 10/02/1987SE |
| K873718 | Child Walking Heel Product No. 4183-132LGF · Traditional | Martin Medical | 10/02/1987SE |
| K873717 | Cushion Tread Walking Heel Product No. 4183-135LGF · Traditional | Martin Medical | 10/02/1987SE |
| K870404 | Colored Casting Tape (Red and Blue)LGF · Traditional | Buckman Co., Inc. | 02/13/1987SE |
| K864092 | Oec Design Orthopedic Cast HeelLGF · Traditional | Military Engineering, Inc. | 12/16/1986SE |
| K861075 | American Orthopaedic Cast Cutter, Model 0295-202LGF · Traditional | Martin Medical | 03/28/1986SE |
| K861074 | American Orthopaedic Cast Cutter, Model 0295-200LGF · Traditional | Martin Medical | 03/28/1986SE |
| K861073 | American Orthopaedic Vacuum 0295-250LGF · Traditional | Martin Medical | 03/28/1986SE |
| K854554 | Delta-Lite Casting ResinLGF · Traditional | Johnson & Johnson Professionals, Inc. | 12/11/1985SE |
| K854341 | Delta-Lite Casting ResinLGF · Traditional | Johnson & Johnson Professionals, Inc. | 11/22/1985SE |
| K843780 | Vent-A-CastLGF · Traditional | Orthopedic Technology, Inc. | 11/14/1984SE |
| K840617 | Masterfoot Cast HeelLGF · Traditional | Seton Products, Inc. | 03/23/1984SE |
| K833084 | MasterhingeLGF · Traditional | Mark One Healthcare Products | 10/14/1983SE |
| K823819 | Cast Toe CoverLGF · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823394 | Walking HeelLGF · Traditional | Orthopedic Systems, Inc. | 12/03/1982SE |
| K822059 | Show'RbagLGF · Traditional | The Healthcare Group Laboratories, Inc. | 07/22/1982SE |
| K812904 | Sterile Orthopedic StockinetteLGF · Traditional | Alba Health Care | 01/18/1982SE |
| K810110 | Cobbler's Chip SplintsLGF · Traditional | Secol Co. | 01/26/1981SE |
| K803141 | Conphar Cast HeelsLGF · Traditional | Conphar, Inc. | 01/09/1981SE |
| K780283 | Inserter, Plug, Bone, LidgeLGF · Traditional | Depuy, Inc. | 03/17/1978SE |